United States Pharmacopeia: Pharmaceutical Compound-Sterile Preparations Pt 3

Question 1

A ____ is more than one unit of a product compounded in a single process

Answer 1

Batch

Question 2

A ____ (BUD) is the date and time at which a compound-sterile preparation (CSP) must be discarded and cannot be used any longer

Answer 2

Beyond-use date

Question 3

What is a CSP?

Answer 3

compound-sterile preparation

Question 4

What is a Category 1 CSP (Compound-sterile preparation)?

Answer 4

This is a CSP (Compound-sterile preparation) which has been assigned a Beyond-use date (BUD) of 12 hours or less at room temperature or 24 hours or less refrigerated

Question 5

What is a Category 2 CSP (Compound-sterile preparation)?

Answer 5

This is a CSP (Compound-sterile preparation) which has been assigned a Beyond-use date (BUD) of greater than 12 hours at room temperature or greater than 24 hours refrigerated.

Question 6

A ____ (COA) is a report provided by manufacturer or suppliers to indicate specifications and results of testing for the item

Answer 6

Certificate of Analysis

Question 7

A ____ is a process simulating compounding processes or products to ensure that microbial growth is not present

Answer 7

Media fill test

Question 8

A ____ is a substance used to prevent microbial growth

Answer 8

Preservative

Question 9

____-free is a substance that lacks fever inducing toxins

Answer 9

Pyrogen-free

Question 10

____ testing is testing that ensures a product meets required quality characteristics

Answer 10

Release testing

Question 11

A ____ area (SCA) is a designed space, that contains a primary engineering control (PEC) where category 1 compounds can be prepared

Answer 11

segregated compounding area

Question 12

What does PEC mean?

Answer 12

Primary engineering control

Question 13

____ is a concentrated agent that destroys bacterial and fungal spores when used in a specific time period

Answer 13

Sporicidal